NCT04134663

Comparison of Intranasal Oxytocin Effects Using Co-administration With a Vasoconstrictor

Completed NA Last updated 11 February 2022

What this trial tests

NA trial testing vasoconstrictor and oxytocin treatment in Healthy in 96 participants. Completed in 20 July 2021.

Timeline

2 March 2019

Primary endpoint
18 June 2021

20 July 2021

Quick facts

Lead sponsor	University of Electronic Science and Technology of China
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	96
Start date	2 March 2019
Primary completion	18 June 2021
Estimated completion	20 July 2021
Sites	1 location across China

Drugs / interventions tested

• vasoconstrictor and oxytocin treatment — full drug profile →
• vasoconstrictor's placebo and oxytocin treatment — full drug profile →
• vasoconstrictor and oxytocin's placebo treatment — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

University of Electronic Science and Technology of China

Who can join

Adults 18 to 30, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to dissociate direct from indirectly mediated effects of intranasal oxytocin administration by using treatment with or without prior intranasal administration of a vasoconstrictor to reduce peripheral increases in peptide concentrations. Primary outcomes of the randomized placebo-controlled double-blind experiment are blood oxytocin concentration and oxytocin-associated responses in central and peripheral systems.

Intranasal application of the neuropeptide oxytocin has been reported to produce a number of neural, physiological and behavior effects which may be of potential therapeutic relevance, but it is unclear the extent to which they are mediated directly via the peptide entering the brain or indirectly as a result of increased peripheral concentrations. In the current placebo-controlled, double blind experiment on healthy adult male subjects the investigators will measure the effects of a single dose of intranasal oxytocin (24IU) on brain activity (using electroencephaolography - EEG) as well as on cardiac (heart-rate and heart-rate variablility) and gastric (electrogastrogram - EGG) activity and physiological arousal (skin conductance response - SCR). The pattern of functional effects observed will be compared with subjects receiving intranasal pretreatment with a vasoconstrictor prior to oxytocin in order to reduce the amount of oxytocin entering the peripheral circulation. The investigators hypothesize that prior administration of the vasoconstrictor will greatly reduce blood oxytocin concentrations following intranasal oxytocin treatment. Where neural/physiological effects are also affected, this will indicate an indirectly mediated action of intranasally administered oxytocin whereas if they are not this will indicate a directly mediated action.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sniffing oxytocin: Nose to brain or nose to blood?
   Yao S, Chen Y, Zhuang Q, Zhang Y, et al · · 2023 · cited 24× · PMID 37185959 · DOI 10.1038/s41380-023-02075-2